Garland, TX, United States

Galt Medical Corporation recalls

5 recalls recorded since 2018, most recently on 26 June 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.

Recalls5

Ongoing (FDA)3

Terminated or completed2

Class I (FDA)0

Recall started: 26 June 2026
Reason: Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
Distribution: US Nationwide distribution in the state of MN.
Initiated: Voluntary: Firm initiated
Recall number: Z-2917-2026

Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock

Recall started: 27 March 2025
Reason: Due to a potential open seal in the sterile barrier packaging.
Distribution: Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1734-2025, Z-1732-2025, Z-1733-2025, Z-1737-2025, Z-1736-2025, Z-1735-2025, Z-1731-2025

GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.
B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system f
B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and othe
Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary a
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 0
GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.

Recall started: 8 May 2023
Reason: Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.
Distribution: Worldwide - US Nationwide distribution in the states of PA, UT, FL, PA, OH, GA, MA, NV, CA, NY, NJ and the countries of UK, AU, TR, FR, CH, NO.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1968-2023, Z-1969-2023

Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)

Recall started: 16 November 2020
Terminated: 7 November 2022
Reason: Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
Distribution: U.S.: FL, GA, MA, NC, NJ, OH, PA, Puerto Rico and UT. O.U.S: Canada, Netherlands, Turkey, United Kingdom, and UAE
Initiated: Voluntary: Firm initiated
Recall number: Z-0568-2021

Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16

Recall started: 2 May 2018
Terminated: 20 July 2020
Reason: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
Distribution: U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico; OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2560-2018, Z-2563-2018, Z-2565-2018, Z-2562-2018, Z-2561-2018, Z-2558-2018, Z-2564-2018, Z-2559-2018

1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06,
Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05
Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055
1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03
1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14;
TVS LPA, Catalog #: DIL-059-00
1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.